Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Endometritis; Operation Wound; Infection

Treatments: Drug: Saline solution; Drug: Clorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03442218

MHST2014-20

Details and patient eligibility

About

To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).

Enrollment: 203 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with gestation between 34 and 41 6/7 weeks.
• Premature rupture of membranes (> 6 hours).
• Use of prophylactic antibiotic 1 hour previous to cesarean section.

Exclusion criteria

• Any source of infection diagnosed previous to surgery.
• Fever of unknown origin previous to surgery.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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203 participants in 2 patient groups, including a placebo group

Clorhexidine

Experimental group

Description:

Vaginal wash with clorhexidine solution

Treatment:

Drug: Clorhexidine

Saline solution

Placebo Comparator group

Description:

Vaginal wash with saline solution

Treatment:

Drug: Saline solution